Evolution in CSV Part 2 of 6: Siren Song of the Electronic Document

Over the years we have seen a steady increase in companies
moving away from paper-based validation to electronic based approaches after
the FDA introduced 21 CFR Part 11, which addresses the use and control of
electronic signatures. When utilized correctly, this opens the door to
numerous potential process and solution improvements in CSV, yet many teams
have failed to take full advantage of these improvements. Understanding Part 11 and moving to
electronic based systems is a step in the right direction, but it’s important
to understand that not all variants of electronic based CSV methodologies are
created equal. At the lowest rung of
these variants, I present the electronic document.

The conversion from a paper document to an electronic
document is a pit fall that many teams have fallen into under the false hope of
making forward progress in CSV. It seems
like process evolution, it seems more modern, it seems like improvement, and it
somewhat is in some areas, but only barely.
The reality is that the shift from a paper document to an electronic
document-based approach to CSV is not nearly as much of a leap as one would
hope. When distilled down, little new is being achieved other than simply
moving the same paper-based process and documents to a computer screen instead
of a physical piece of paper perhaps adding some templates and workflow. It’s putting a slightly modern spin on the
inefficient, antiquated paper-based methodology and brings with it many of the
same downsides.

To throw in a quick metaphor to color things up a bit, teams
that have utilized 21 CFR Part 11 to replace the paper document with an
electronic document methodology have essentially only used the prison guard’s
keys to loosen their shackles for a little extra comfort instead of using them
to escape from the prison altogether.

This methodology adoption should by no means be considered
fully modernizing CSV processes or solutions, nor should it be considered the
fullest utilization of what 21 CFR Part 11 offers. So why have so many teams opted to leverage
this variant of electronic based approaches to meet their CSV requirements?

To start, moving to an electronic document-based system
comes with a certain sense of familiarity and with familiarity comes comfort.
Adopting the electronic document looks and feels much the same as
processes that were already in place, so in theory it would not take a huge
revision in SOP’s, nor would it require a large investment in retraining
employees.
Afterall, introducing change into a regulated
environment can be a difficult task in and of itself (a topic which we will
cover in more depth down the road) and an electronic document with an
electronic signature feels like just enough evolution without having to
introducing revolution, so the burden of positioning internal buyoff is
lessened.

As an added bonus, the electronic document does remove some
of the more obvious headaches of the paper-based approach by allowing for a
simplified method of review and approval, document retrieval and document sharing.
No more printing and signing documents, storing boxes of binders filled
with validation documentation, scouring the annals of storage facilities
looking for pieces of the validation puzzle at an auditor’s request, etc. Couple these (small) benefits with the power
of something familiar and comfortable in a regulated environment and it becomes
easy to understand the appeal.

However, these benefits are relatively insignificant in contrast to the limitations of the document, and familiarity and comfort should not be reason enough to shy away from necessary innovations. As mentioned earlier, the electronic document carries with it many of the negative characteristics and limitations of the paper document, the operative word in both methodologies being “document”. Regardless of whether it’s a piece of paper with wet signatures or a PDF with electronic signatures, the static document simply does not lend itself to modern demands on development and testing teams.

Jason Secola is the Support Sales Manager at Tx3 Services and has been with the company since 2016. Jason began working with the larger portion of the existing Tx3 team dating back to 2007 when he got his first start in the world of application testing and later began a focus on testing in a regulated environment.

Author: Jason Secola

Jason Secola is the Support Sales Manager at Tx3 Services and has been with the company since 2016. Jason began working with the larger portion of the existing Tx3 team dating back to 2007 when he got his first start in the world of application testing and later began a focus on testing in a regulated environment.
He currently resides near Sacramento, CA.
View all posts by Jason Secola